NCT05892120

Brief Summary

This is an experimental study which aims to explore the effectiveness of a smartphone app for medication adherence (MedAdhere app) among schizophrenic patients for eight weeks.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2023

Completed
16 days until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 7, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

June 7, 2023

Status Verified

May 1, 2023

Enrollment Period

2 months

First QC Date

May 16, 2023

Last Update Submit

June 6, 2023

Conditions

Medication Adherence

Keywords

schizophreniamedication adherencesmartphone apppsychiatric symptoms

Outcome Measures

Primary Outcomes (3)

  • psychiatric symptoms

    The positive and negative syndrome scale was used to measure participants' psychiatric symptoms. Of the 30 items on the scale, seven are positive symptoms, seven are negative symptoms, and 16 are general psychopathology symptoms. Symptom severity for each item is rated according to the anchoring points in the 7-point scale (1 = absent; 7 = extreme) that best describe the symptom (Kay et al., 1987). The PANSS score is the sum of ratings across items, ranging from 7 to 49 for the Positive, Negative Scales, and 16 to 112 and 16 to 112 for the General Psychopathology Scale.

    Change from Baseline psychiatric symptoms at 8 weeks

  • cognitive functions

    The Mini-Mental State Examination was used to measure participants' cognitive functions. The MMSE consists of 15 questions for assessing the following seven cognitive domains: orientation in time and place, memory registration and recall, attention and calculation, and language. The total MMSE score ranged from 0 to 30, and higher scores indicate better cognitive functions.

    Change from Baseline cognitive functions at 8 weeks

  • Medication adherence rate

    Utilizing cloud-based platforms to compute the medication adherence rate.

    Change from Baseline Medication adherence' rate at 8 weeks

Study Arms (2)

control group

The control group only received usual care, the PANSS and MMSE were used to assess psychiatric symptoms and cognitive functions before (week 0) and after 8 weeks.

experimental group

The experimental group use the MedAdhere app for eight weeks, the PANSS and MMSE were used to assess psychiatric symptoms and cognitive functions before (week 0) and after (week 8) intervention.

Behavioral: the MedAdhere app

Interventions

the MedAdhere appBEHAVIORAL

The experimental group downloaded and used the MedAdhere app on their personal smartphones during this 8-week study

experimental group

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Schizophrenia is a brain disorder that is possibly related to the reduction of neural connections in the prefrontal cortex or imbalances in dopaminergic neurons in brain. It can be induced by genetic, social, physiological, psychological, and other factors, resulting in cognitive, emotional, behavioural, and perception dysfunction. At present, new generations of anti-psychotic drugs have become available, allow patients to stabilise their condition with less side effect by receiving regular drug treatment. However, medication non-adherence can cause disorder progression, compromise the patient's quality of life, and increase medical expenses

You may qualify if:

  • schizophrenia
  • aged 20 to 65 years
  • able to read traditional Chinese
  • owning a smartphone
  • currently admitted at a psychiatric day-care center

You may not qualify if:

  • Intellectually disabled or severe cognitive function impairment (Dementia)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University

Kaohsiung City, 80708, Taiwan

Location

Related Publications (1)

  • Chen HH, Hsu HT, Lin PC, Chen CY, Hsieh HF, Ko CH. Efficacy of a Smartphone App in Enhancing Medication Adherence and Accuracy in Individuals With Schizophrenia During the COVID-19 Pandemic: Randomized Controlled Trial. JMIR Ment Health. 2023 Dec 14;10:e50806. doi: 10.2196/50806.

    PMID: 38096017DERIVED

MeSH Terms

Conditions

Medication AdherenceSchizophrenia

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorSchizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
12 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2023

First Posted

June 7, 2023

Study Start

June 1, 2023

Primary Completion

July 25, 2023

Study Completion

December 31, 2023

Last Updated

June 7, 2023

Record last verified: 2023-05

Locations

TW(1)